GLYCOPYRROLATE

Product NDC
13107-014
11-digit product format
131070014
Labeler code
13107
Product ID
13107-014_1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA202675
Marketing category
ANDA
Marketing start
2023-02-28
Substance
GLYCOPYRROLATE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202675-001GLYCOPYRROLATEGLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15
A202675-002GLYCOPYRROLATEGLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202675-001AA
A202675-002AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202675-001GLYCOPYRROLATE1MGTABLET / ORALAA2013-04-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A202675-002GLYCOPYRROLATE2MGTABLET / ORALAA2018-10-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202675-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202675-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202675-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202675-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202675-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202675-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202675-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202675-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202675-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202675-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202675-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202675-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202675-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202675-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202675-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202675-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202675-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202675-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202675-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202675-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202675-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202675-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202675-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202675-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202675-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202675-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202675-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202675-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202675-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202675-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202675-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202675-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202675-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202675-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202675-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202675-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202675-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202675-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202675-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202675-002AA1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
GLYCOPYRROLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V92SO9WP2IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197738Internal RxNorm lookup
197739Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
677f8495-a870-45b6-bb65-75b449f040ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
13107-014-012023-03-24These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-102023-03-24These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-112023-03-24These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-992023-03-24These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-012023-01-30These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-102023-01-30These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-112023-01-30These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961
13107-014-992023-01-30These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-014-01GLYCOPYRROLATE100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-014-01EA - Each13107-0141c403a8a-85b6-4384-aae7-5b3fc6aa62fa12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [AUROLIFE PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-014GLYCOPYRROLATE TABLET [AUROLIFE PHARMA LLC]8Current NDC, Legacy NDC, 1 package rows20240820_677f8495-a870-45b6-bb65-75b449f040ce.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
GLYCOPYRROLATEGLYCOPYRROLATEAurolife Pharma LLC677f8495-a870-45b6-bb65-75b449f040ce2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
ndc (product): 13107-014
GLYCOPYRROLATEGLYCOPYRROLATEAmerican Health Packaging6404fc8e-d109-4950-9dca-c8a85ad90cf32025-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675
GlycopyrrolateGLYCOPYRROLATEAvPAKbd497783-e2d1-130c-e053-2995a90a7fb92025-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202675
application number: ANDA202675

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSN21c7d201-c0b8-4f16-be4a-681d0b22791e12
197738glycopyrrolate 1 MG Oral TabletSCD21c7d201-c0b8-4f16-be4a-681d0b22791e12
197738glycopyrrolate 1 MG Oral TabletPSN677f8495-a870-45b6-bb65-75b449f040ce9
197739glycopyrrolate 2 MG Oral TabletPSN677f8495-a870-45b6-bb65-75b449f040ce9
197738glycopyrrolate 1 MG Oral TabletSCD677f8495-a870-45b6-bb65-75b449f040ce9
197739glycopyrrolate 2 MG Oral TabletSCD677f8495-a870-45b6-bb65-75b449f040ce9
197738glycopyrrolate 1 MG Oral TabletPSNbd497783-e2d1-130c-e053-2995a90a7fb94
197738glycopyrrolate 1 MG Oral TabletSCDbd497783-e2d1-130c-e053-2995a90a7fb94
197738glycopyrrolate 1 MG Oral TabletPSN6404fc8e-d109-4950-9dca-c8a85ad90cf33
197738glycopyrrolate 1 MG Oral TabletSCD6404fc8e-d109-4950-9dca-c8a85ad90cf33
197738glycopyrrolate 1 MG Oral TabletPSN5ed930b7-a36e-4bf8-b1d1-dad238d3dd181
197738glycopyrrolate 1 MG Oral TabletSCD5ed930b7-a36e-4bf8-b1d1-dad238d3dd181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-014-0113107001401100 TABLET in 1 BOTTLE (13107-014-01) 100 tablet2023-02-280000-00-00NoNoCurrent
13107-014-101310700141010 BLISTER PACK in 1 CARTON (13107-014-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2013-04-150000-00-00NoNoCurrent
13107-014-111310700141110 TABLET in 1 BOTTLE (13107-014-11) 10 tablet2013-04-150000-00-00NoNoCurrent
13107-014-99131070014991000 TABLET in 1 BOTTLE (13107-014-99) 1000 tablet2013-04-150000-00-00NoNoCurrent